Medical compositions, methods of making and using those compositions, and kits including those compositions

ABSTRACT

Disclosed here are compositions comprising powdered hemp seed, an emulsifier/dispersant such as lecithin (particularly soya lecithin), cannabis, and optionally other additives and excipients. Also described are methods of making the compositions. The compositions may be used, for instance, in the treatment of pain and for their anti-emetic (anti-nausea and anti-vomiting) properties, as well as for the treatment of anorexia and appetite enhancement. Kits containing the compositions, arranged for proper sequential dosing, and optionally including instructions for use are also disclosed.

RELATED APPLICATIONS

This patent application claims priority to U.S. Provisional PatentApplication Ser. No. 61/685,956, entitled “Medical Compositions, Methodsof Making and Using Those Compositions, And Kits Including ThoseCompositions” filed on Mar. 28, 2012, which application is herebyincorporated by reference in its entirety for all purposes.

FIELD

Disclosed here are compositions comprising powdered hemp seed, anemulsifier/dispersant such as lecithin (particularly soy lecithin),cannabis, and optionally other additives and excipients. Also describedare methods of making the compositions. The compositions may be used,for instance, in the treatment of pain and for their anti-emetic(anti-nausea and anti-vomiting) properties, as well as for the treatmentof anorexia and appetite enhancement. Kits containing the compositions,arranged for proper sequential dosing, and optionally includinginstructions for use are also disclosed.

BACKGROUND

Cannabinoids of natural origin are compounds derived from plantscommonly known as marijuana. Among the several dozen cannabinoidcompounds characterizing marijuana, tetrahydrocannabinols (THC), andΔ⁹-tetrahydrocannabinol (Δ⁹-THC) in particular, are considered to bethose most active. These compounds possess several properties, e.g., ananalgesic effect, an anti-inflammatory activity, the reduction of theblood and intraocular pressure, and an antiemetic activity, that may betherapeutic both in mammals and in human beings.

Additionally, such preparations derived from natural origin have beeneffectively used as anti-emetics for treatment of nausea and vomitingand for enhancement of appetite, mainly in AIDS patients. (Mechoulam,R., “Cannabinoids as Therapeutic Agents” CRC Press, Boca Raton, Fla.1-19, 1986).

The pharmacological action of cannabinoids appears directly correlatedto their affinity towards two different classes of specific receptorsbelonging to the family of the “G protein-coupled” receptors: the CB1receptors, located in the central nervous system besides that inperipheral tissues, and the CB2 receptors, found in the cerebellum (Q.J. Lu et al.; Visual Neurosci.; 2000, 17, 91-95) but which are mostlyfound in peripheral tissues (M. Glass; Progr. Neuro-Psychopharmacol.&Biol. Psychiat.; 2001, 25, 743-765). In the brain, the CB1 receptorsare found in the hippocampus, in the cortical regions, in thecerebellum, and inside the basal ganglia. Among the peripheral tissueswherein the CB1 receptors have been found, the testicles, the smallintestine, the vesica, the deferent duct can be mentioned. CB1 receptorshave also been identified in the human eye, variously in the retina, inthe iris, and in the ciliary body (A. Porcella et al.; Molecular BrainResearch; 1998, 58, 240-245; A. Porcella et al.; European Journal ofNeuroscience; 2000, 12, 1123-1127).

The CB2 receptors are largely located in the marginal zones of thespleen, in tonsils, in several cells of the immune system, asmacrophages, monocytes, the cells of the bone marrow, of thymus, and ofpancreas. Other cells of the immune system having CB2 receptors are T4and T8 cells, the polymorphonucleated leucocytes, in particular thecells called “natural killers” and lymphocytes B.

The native active constituent, delta 9-tetrahydrocannabinol (Δ⁹-THC), issynthetically produced, prescribed, and sold today. In the U.S. andCanada, (Δ⁹-THC) is nominated as “dronabinol” under the mark “MARINOL®”by Solvay Pharmaceuticals and, under license, by PAR Pharmaceuticals.The U.S. Food and Drug Administration has approved MARINOL® for thetreatment of anorexia and wasting in AIDS patients, as well as forrefractory nausea and vomiting by patients undergoing chemotherapy.

DESCRIPTION

Disclosed here are compositions comprising cannabis, anemulsifier/dispersant such as lecithin (particularly soya lecithin),natural marijuana components, and optionally other additives andexcipients. Methods of making the compositions are also described. Thecompositions may be used, for instance, in the treatment of pain and fortheir anti-emetic (anti-nausea and anti-vomiting) properties, as well asfor the treatment of anorexia and appetite enhancement. Kits containingthe compositions, arranged for proper sequential dosing, and optionallyincluding instructions for use are also disclosed.

Compositions

My compositions comprise hemp seed powder, one or moreemulsifiers/dispersants such as lecithin (particularly soya lecithin),cannabis, and (optionally) other additives and excipients.

Hemp Seed Powder

Hemp seed powder is added to my compositions to provide a measure ofdispersion and dilution to the natural cannabis component. Because hempseed powder is derived from a plant related to cousins—cannabis sativaand cannabis indica—the hemp seed powder and cannabis components blendtogether well. In addition to acting as a dispersal medium for thecannabis concentrate, the hemp seed powder contains beneficial protein,fats, fiber, and omega-3 and -6 fatty acids.

The powder may be formed by communition, e.g., by grinding or milling orother suitable procedure, of the seed to a fine powder having a particlesize between that of powdered sugar to granulated sugar. The particlesize is not particularly important and is selected to provide adequatedispersal of the other components in my composition.

Although a variety of hemp seed powders may be utilized in mycompositions, I prefer to use powders often sold as hemp seed protein orhemp seed flour and is formed by cold-processing raw, live hemp seeds.Those cold processing steps include a mechanical step of removing thehard shells from the hemp seed's (“dehulling”) and mechanically pressingthe dehulled hemp seeds, e.g., by expeller expressing the seed coreswithout hexane or other solvents, to remove hemp oil from the seeds andto form a seed cake. Dehulling the seeds reduces the crude fiber contentof the seed cake while increasing the protein concentration of theremaining seed meats. The seed cake is then milled or otherwise reducedto particulate form to produce my preferred hemp seed powder. I preferto utilize hemp seed powder that is also certified organic and isotherwise free of pesticides and the like.

Although my preferred hemp seed powder is that described just above,hemp seed powder produced by other procedures may also be utilized withlesser effect. For instance, the following steps may be used to processhemp seed to separate the included hemp oil from the seed cake used toprepare hemp seed powder: preparation, cracking and dehulling,conditioning, milling, flaking or pressing, and extracting. Each ofthese steps will be discussed in more detail herein below. These stepsare currently used in the commercial separation of seed oils. A personof ordinary skill would know that the steps may be combined, used in adifferent order, or otherwise modified.

Generally, the preparation step includes an initial cleaning process,which removes stones, dirt, foreign bodies, and other debris collectedduring the harvest and storage of the seeds. Removal of such extraneousmatter may positively affect the quality of the final hemp seed powderby removing compounds that negatively impact its chemical stability.Preferably, ripe, unbroken seeds are used. These seeds have reducedlevels of chlorophyll and reduced levels of free fatty acids.

After the preparation step, the seeds may then be cracked and dehulled.Cracking and dehulling may be accomplished in a variety of ways. Forexample, the seeds may be cracked and dehulled using a seed cracker,which mechanically breaks the hemp seeds, releases the hulls, anddirectly exposes the inner seed meat to air. After cracking, the hullsmay be separated from the seed meats by a dehuller. The dehullertypically separates the hulls from the seed meats using the densitydifference between the hulls and the seeds. The hulls are not as denseas the seed meats. For example, a dehuller using aspiration or airflotation will separate the hulls from the cracked seed meats.Optionally, after dehulling, the hulls may be sieved to recover smallseed meat particulates, or fines, generated during cracking of theseeds. After recovery, the fines may be added to the seed meats prior tothe conditioning step.

Once the seeds are cracked, it is desirable to minimize the exposure ofthe seed meats to oxygen to reduce oil oxidation and improve the qualityof the seed cake. It is desirable to minimize oxygen exposureindependently in each of the described processing steps.

Once the seeds are cracked and dehulled, they may be subjected to aconditioning step to make the seed meats pliable prior to furtherprocessing. Conditioning also ruptures oil bodies in the seed meats.Further processing, e.g., by flaking, grinding or other millingtechnology, is made easier by having pliable seed meats at this stage.If necessary, moisture typically is removed from or added to the seedmeats to achieve a 6-10 wt. % moisture level. If moisture is removed,this process step is called toasting and if moisture is added, theprocess step is called cooking. Typically, the seed meats are heated to40-90° C. with steam which is dry or wet depending on the direction ofadjustment of the moisture content of the seed meats. As noted above,the conditioning step should take place under conditions minimizingoxygen exposure.

Once the seed meats are conditioned, they may be milled to a desiredparticle size or flaked to a desired surface area. Again, the flaking ormilling steps may be carried out under conditions minimizing oxygenexposure. Flaking or milling is done to increase the surface area of theseed meats and also to further rupture the oil bodies in the seed bodythereby facilitating a more efficient extraction.

Any of a variety of milling technologies is appropriate and is wellknown. The considerations when choosing a method of milling and aresulting particle size include the oil content in the seed and thedesired efficiency of the extraction of the seed meats or the seed. Whenflaking the seed meats, the flakes may typically be from about 0.1 toabout 0.5 mm thick.

Optionally, after the seed meats are milled, they may be pressed tolower their oil content. Seed meats are often pressed when the oilcontent of the seed meats is greater than about 30%, by weight. However,seed with higher or lower oil contents may be pressed as well. The seedmeats may be pressed, for example, in a hydraulic press or mechanicalscrew. The seed meats may be heated to a temperature, e.g., of less thanabout 55° C., during pressing.

After pressing, the resulting hemp oil may be passed through a screen,collected, and filtered. The oil collected in this step is called “firstpress oil.” The so-pressed seed meats are called “seed cake.” The seedcake may contain residual oil. The seed cake may optionally be subjectedto a solvent extraction step or steps. Compositions that include seedcakes that have been subjected to solvent extraction are within thescope of my invention.

That residual hemp oil may be extracted from the seed meats or seed cakeby contact with an effective solvent. Aliphatic solvents, such asn-hexane and iso-hexane are effective solvents for extracting theremaining oil. Such aliphatic solvents are desirably degassed prior tocontact with the seed cake. Such an extraction may be carried out in avariety of ways; e.g., the extraction may be a batch or continuous,co-current or counter-current in nature. After extraction, the solventmay separated from the hemp oil by, e.g., distillation, evaporation,stripping, etc. The solvent may be removed from the seed cake by heatingor vacuum stripping. Great care should be taken to remove all vestigesof the solvent should these procedures be selected.

If necessary, the seed cake may finally be comminuted, e.g., by grindingor milling or other suitable procedure, to a fine powder as discussedabove.

Lecithin

The second component of my composition comprises lecithin, typically ordesirably soy lecithin. The soy lecithin powder acts as an emulsifier,dispersant, and stabilizer that evenly disperses the hemp seed powderand the cannabis concentrate and gives my formulation a consistenttexture. The lecithin further acts as a carrier for the cannabiscannabinoids present in my composition to pass through the intestinalmucosa into the bloodstream.

Preferably, my composition contains a soy-derived lecithin in powderform that has been de-oiled and, for the purposes of mixing thecomposition, of size 35-40 mesh. Preferably, the lecithin is certifiedorganic and completely pesticide-free.

Although soy lecithin as described just above is preferred, otherlecithins may be included with or in lieu of soy lecithin. For instance,sunflower-based and egg-based lecithins are also acceptable.

Generally, lecithin refers to a group of yellow-brownish fattysubstances occurring in animal and plant tissues made up of phosphoricacid, choline, fatty acids, glycerol, glycolipids, triglycerides, andphospholipids (e.g., phosphatidylcholine, phosphatidylethanolamine, andphosphatidylinositol). The principal phospholipids in soy and sunflowerlecithin are phosphatidylcholine, phosphatidylinositol,phosphatidylethanolamine, and phosphatidic acid.

Cannabis

My composition comprises a third component denoted “cannabis,” whichrefers to natural compositions, typically resinous in nature, containingactive cannabinoids, particularly THC (or THCA), separated frommarijuana plants. Cannabis Indica and Cannabis Sativa are two strains ofthe marijuana plant. In addition to the medical benefits detailedelsewhere herein, each strain has its own individual psychoactiveproperties. The Indica strain is typically used for relaxation, stressand pain relief, and to provide a sense of calm and serenity. The Sativatypically produce a more energetic cerebral effect, often characterizedas uplifting and stimulating, as well as providing pain relief.

The cannabis component includes hair-like, translucent resin glandsknown as trichomes that naturally protrude from the buds, leaves, andother sites on the plant. The cannabis component may include otherportions of the cannabis or marijuana plant in addition to the resin.

The concentrate or cannabis component may be made using a processdesigned to extract and preserve the psychoactive resins from thecannabis plant. The process includes steps of immersing, chilling, andagitating in ice water. The cannabis leaf, flowers, buds, etc. are firstchopped and then mixed into an ice and water bath; the mixture isagitated in a manner similar to a washing machine. The cold water andice harden the resins and cause them to break off from the plant leavesand buds.

The hardened particulates containing the resins are separated from thewater bath and are used as the cannabis concentrate or composition. Theleaves, buds, etc. are also separated from the water. Extraneous leavesmay be separated from the hardened resins. Some variations of thisprocedure produce a mixture known as “cold water hash.”

The resulting cannabis component is measured for: 1.) potency (e.g.,weight percentage of (Δ⁹-THC)), 2.) pesticide residues, and 3.)colony-forming unit (CFU) counts. Cannabis concentrates having anypesticide residues or that exhibit CFU counts above 200,000 arerejected.

Determination of the potency of the cannabis component allows productionof doses having specific, predetermined amounts of THC, as discussedbelow.

Excipients

My compositions or formulations may optionally contain one or moreexcipients. Examples of such excipients include, for instance:

-   -   1.) diluents (or vehicles or disintegrating agents) such as        starches; agar; microcrystalline cellulose; sugars such as        lactose, dextrose, glucose, mannitol, sucrose, sorbitol;        gelatin, gums such as acacia and tragacanth gums, dicalcium        phosphate, tricalcium phosphate, monocalcium phosphate, sodium        phosphate, sodium carbonate, calcium citrate, calcium carbonate,        sodium bicarbonate, carboxymethyl cellulose, pregelatinized corn        starch, pregelatinized starch, celluloses, cross-linked        carboxymethylcellulose, cross-linked polyvinylpyrrolidone,        calcium-sodium alginate complexes, clays, alginates, sodium        starch glycolate, and disintegration agents such as are used in        tablet preparations;    -   2.) lubricants such as talc, stearic acid, zinc stearate,        calcium stearate, magnesium stearate, polyethylene glycols,        silica, and hydrogenated vegetable oils and similar materials;    -   3.) binders such as acacia, alginic acid and salts thereof;        sucrose, glucose, various polyethylene glycols,        polyvinylpyrrolidone, cellulose derivatives, ethyl cellulose,        methyl cellulose, hydroxyethylcellulose, hydroxypropylcellulose,        hydroxypropyl methylcellulose, magnesium aluminum silicate,        tragacanth gums, corn or maize starch, shellac, gelatin, gum        arabic, polyvinyl pyrrolidone, polyvinylpyrrolidone/vinyl        acetate copolymers, polyvinyl alcohol, polyacrylic acid,        polymethacrylates, polymethacrylic acid, polysaccharide acids,        clays such as bentonites, sorbitol, pregelatinized starch and        similar materials;    -   4.) colorants such as ferric oxides, FD&C dyes and similar        materials;    -   5.) anti-oxidizing agents such as ascorbic acid, tocopherol,        vitamin A, β-carotene, sodium hydrogen sulfite, sodium        thiosulfate, sodium pyrosulfite, citric acid, and similar        materials;    -   6.) flavoring agents;    -   7.) anti-aggregating agents such as stearic acid, talc, light        anhydrous silicic acid, and hydrous silicon dioxide, and similar        materials;    -   8.) absorption promoters, typically surfactants, such as higher        alcohols, higher fatty acids, glycerin fatty acid esters, and        similar materials;    -   9.) surfactants such as sodium lauryl sulfate, sorbitan        monooleate, polyoxyethylene sorbitan monooleate, polysorbates,        polaxomers, bile salts, glyceryl monostearate, and similar        materials;    -   10.) solubilizing agents, often organic acids, such as fumaric        acid, succinic acid, malic acid, and similar materials;    -   11.) stabilizers such as benzoic acid, sodium benzoate, ethyl        parahydroxybenzoate, and similar materials;    -   12.) revitalizing ingredients such as creatine, taurine, vitamin        B₁, vitamin B derivatives, amino acids and mixtures thereof, and        similar materials;    -   13.) pH modifiers (or buffers) such as suitable organic acids or        alkali metal salts of those organic acids. Suitable organic        acids include benzoic acid, fumaric acid, malic acid, maleic        acid, glutaric acid, citric acid, tartaric acid, succinic acid,        adipic acid and the like. Examples of alkali metal salts of        those organic acids include lithium, sodium, and potassium        salts, in particular, the sodium salt of citric acid (i.e.,        sodium citrate).

Excipients may be included in the compositions in amounts between about5% to 90% by weight, commonly less than about 15% by weight asappropriate or desired for the particular purpose.

Additionally, drug formulations are discussed in, for example,Remington's, The Science and Practice of Pharmacy (2000); Lieberman, H.A. and Lachman, L., Eds., Pharmaceutical Dosage Forms, Marcel Decker,New York, N.Y., 1980; and Liebeman et al., Pharmaceutical Dosage Forms(Volumes 1-3, 1990).

When the excipient serves as a diluent, it may be in the form of asolid, semi-solid or liquid material, which acts as a vehicle, carrieror medium for the active ingredient. Thus, the compositions may be inthe form of a tablet, pill, powder, lozenge, sachet, cachet, troche,soft and hard gelatin capsule, sterile packaged powder, dispensablepowder, or granule.

Method of forming the Composition

My compositions comprise or consist essentially of the 1.) cannabiscomponent containing specific predetermined doses of THC, 2.) lecithin,and 3.) hemp seed.

Doses of my composition desirably are produced in the form of gelcapsules or tablets containing a specific amount of THC. Therefore, itis necessary to first calculate and to provide a specific weight of thecannabis component (having a particular THC concentration), to provide aspecific relative weight of the soy lecithin, and to provide theremainder of the composition in the form of the hemp seed powder.

These three components, optionally with any excipients, are thenwell-mixed desirably using a mechanical mixer.

The mixture is then finely ground and sifted. Any oversize particles arere-ground and recycled to the mixture. The mixture may be re-ground asufficient number of times that a specific batch of the composition allpasses through a small mesh screen.

The mixture is then heated to a temperature, e.g., between about 200° F.and about 250° F., for a short period of time, e.g., about 20-40minutes, preferably about 30 minutes. The purpose of the heating step isto de-carboxylate the THC-carboxy molecule naturally occurring in thecannabis component and to convert it to the active THC form. The heatingstep additionally sterilizes the mixture.

After cooling, the mixture or composition may then be placed in thedesired gel capsules or otherwise formed into suitably sized doses.

Forms

My compositions or formulations are typically provided in the form of asoft or hard-shelled gelatin or plant vegetarian gelatin capsule or an(optionally) coated tablet.

Soft and hard-shelled gelatin or plant vegetarian gelatin capsules arewell known in the pharmaceutical art and need not be discussedadditionally here. My compositions containing the components discussedabove and made using the procedure also discussed above are simplyintroduced into the capsules for use.

Tablet forms of my composition or formulation may include, for example,one or more of lactose, mannitol, corn starch, potato starch,microcrystalline cellulose, acacia, gelatin, colloidal silicon dioxide,talc, magnesium stearate, stearic acid, and other excipients, colorants,diluents, buffering agents, moistening agents, preservatives, flavoringagents and pharmaceutically compatible carriers.

One acceptable tablet manufacturing process may employ one or acombination of methods: (1) dry mixing, (2) direct compression, (3)milling, (4) dry or non-aqueous granulation, (5) melt granulation, or(6) fusion. See, Lachman et al., The Theory and Practice of IndustrialPharmacy (1986).

Such tablets may also comprise film coatings, which disintegrate uponoral ingestion or upon contact with diluent.

Compressed tablets are typically solid dosage forms prepared bycompacting a formulation containing an acid-labile pharmaceutical agentand/or buffering agent and/or excipient selected to aid the processingand improve the properties of the product. The term “compressed tablet”generally refers to a plain, uncoated tablet for oral ingestion,prepared by a single compression or by pre-compaction tapping followedby a final compression.

The tablets or pills of the present invention may be coated or otherwisecompounded to provide a dosage form affording the advantage of improvedhandling or storage characteristics. For example, the tablet or pill cancomprise an inner dosage and an outer dosage component, the latter beingin the form of an envelope over the former.

My compositions may be formed as rapidly disintegrating tablets orpowders, chewable tablets, lozenges, troches, or swallowable tablets.Effervescent salts may be used to disperse medicines in water for oraladministration. Effervescent salts are typically granules or coarsepowders containing a medicinal agent in a dry mixture, usually composedof sodium bicarbonate, citric acid and tartaric acid. When the salts areadded to water, the acids and the base react to liberate carbon dioxidegas, thereby causing “effervescence.”

Many other types of release delivery systems are available and known tothose of ordinary skill in the art. They include polymer-based systems,such as polylactic and polyglycolic acid, polyanhydrides andpolycaprolactone; nonpolymer systems that are lipids, including sterols,such as cholesterol, cholesterol esters and fatty acids, or neutralfats, such as mono-, di- and triglycerides; hydrogel release systems;silastic systems; peptide-based systems; wax coatings; compressedtablets using conventional binders (See, for example, Lieberman et al.,Pharmaceutical Dosage Forms, 2 Ed., Vol. 1, pp. 209-214 (1990)), andexcipients; partially fused implants; and the like.

Administration

My compositions or formulations may be administered in a variety or waysdepending in the main upon the selected physical form of thecomposition. The compositions may be administered, e.g., by oraladministration, sublingual administration, transrectal administration,transvaginal administration, and transnasal administration. Among thosemethods, I have had good reception from patients taking hard-shelledgelatin or plant vegetarian gelatin capsules by oral administration.

Cannabinoid Acid Addition Salts

Certain natural cannabinoid compounds of the invention also formpharmaceutically acceptable salts, for example, acid addition salts. Forexample, the nitrogen atoms may form salts with acids. Examples ofsuitable acids for salt formation are hydrochloric, sulfuric,phosphoric, acetic, citric, oxalic, malonic, salicylic, malic, fumaric,succinic, ascorbic, maleic, methanesulfonic, and other mineral andcarboxylic acids well known to those in the art. The salts are preparedby contacting the free base form with a sufficient amount of the desiredacid to produce a salt in the conventional manner. The free base formsmay be regenerated by treating the salt with a suitable dilute aqueousbase solution such as dilute aqueous hydroxide, potassium carbonate,ammonia, and sodium bicarbonate. The free base forms differ from theirrespective salt forms somewhat in certain physical properties, such assolubility in polar solvents, but the acid salts are equivalent to theirrespective free base forms for purposes of the invention. See, forexample, S. M. Berge, et al., “Pharmaceutical Salts,” J. Pharm. Sci.,66: 1-19 (1977).

Combination Therapy Compositions

My compositions may also be used in combination (“combination therapy”)with another pharmaceutical agent or agents indicated for treating orpreventing a selected disorder. Such added agents may include, forexample, opioid or opiate analgesics, NSAIDs, COX-2 inhibitors, andanti-emetics (for example, ondansetron).

The phrase “combination therapy” is meant to include the administrationof my composition in conjunction with another pharmaceutical agent thatis indicated for treating or preventing a disorder in a subject, as partof a specific treatment regimen intended to provide a beneficial effectfrom the co-action of these therapeutic agents for the treatment of adisorder. The beneficial effect of the combination includes, but is notlimited to, pharmacokinetic or pharmacodynamic co-action resulting fromthe combination of therapeutic agents. Administration of thesetherapeutic agents in combination may be carried out over a defined timeperiod (usually substantially simultaneously, minutes, hours, days,weeks, months or years depending upon the combination selected).“Combination therapy” is not intended to encompass the administration oftwo or more of these therapeutic agents as part of separate monotherapyregimens that incidentally and arbitrarily result in the combinationsclaimed here. The term “Combination therapy” is intended to embraceadministration of these therapeutic agents in a sequential manner, whereeach therapeutic agent is administered at a different time. The term isintended to include administration of these therapeutic agents, or atleast two of the therapeutic agents, in a substantially simultaneousmanner. Substantially simultaneous administration may be accomplished,for example, by administering to the subject a single tablet or capsulehaving a fixed ratio of each therapeutic agent or in multiple, singlecapsules, or tablets for each of the therapeutic agents. Sequential orsubstantially simultaneous administration of each therapeutic agent maybe effected by any appropriate route.

For instance, my composition may be administered orally or via asuppository, while the other therapeutic agent of the combination isadministered by any appropriate route for that particular agent, such asvia an oral route, inhalation, a percutaneous route, an intravenousroute, an intramuscular route, or by direct absorption through mucousmembrane tissues.

The term “combination therapy” is also intended to include theadministration of the therapeutic agents as described above in furthercombination with one or more other biologically active ingredients, suchas pain relievers, such as steroidal or nonsteroidal anti-inflammatorydrugs, or agents for improving stomach motility, for example, and withnon-drug therapies such as surgery.

Kits

My compositions and formulations may be assembled in the form of a kitor package containing one or more of the compositions. My compositionsand formulations may be packaged in the form of a kit or package inwhich hourly, daily, weekly, or monthly (or other periodic) dosages arearranged for proper sequential or simultaneous administration. This drugdelivery system may be used to facilitate administration of any of thevariations my compositions including, for instance, agents orcompositions used in combination therapy to facilitate properadministration of the dosage forms. In one variation of my kit, thesystem contains a plurality of doses to be to be administered daily oras needed for symptomatic relief. The kit or package may also contain aset of instructions for the subject.

Definitions

The use of the term “about” in the present disclosure means“approximately,” e.g., +/−5% of the component referred to, and use ofthe term “about” indicates that dosages and amounts outside thosespecified may also be effective and safe, and such dosages and amountsare also encompassed by the scope of the present claims.

A therapeutic agent (or the therapeutic agents) of the present inventionis used in a method, kit, combination, and/or composition in a“disorder-effective amount.” A “disorder-effective amount” is intendedto qualify the amount of an agent (or agents) required to treat orprevent a disorder in a subject, or relieve to some extent one or moreof the symptoms associated with, or related to, a disorder in a subject.In a mammal, this includes, but is not limited to, improving oralleviating the above stated diseases.

The term “prevent” or “prevention,” in relation to a disorder, means nodisorder, condition, or disease development if none had occurred, or nofurther disorder, condition, or disease development if there had alreadybeen development of a disorder, condition, or disease.

The term “disorder-effective amount” means that the dose of atherapeutic agent (or agents) is such that a therapeutic level of agentis delivered to the bloodstream over the term that the composition is tobe used. Such delivery is dependent on a number of variables includingthe time period for which the individual dosage unit is to be used, orthe flux rate of the therapeutic agent into the systemic circulation ofthe subject. It is to be understood that specific dose levels of atherapeutic agent for any particular subject depends upon a variety offactors including the activity of the specific compound employed, theage, body weight, general health, sex, and diet of the subject, the timeof administration, the rate of excretion, the drug combination, and theseverity of the particular disorder being treated and form ofadministration. Treatment dosages generally may be titrated to optimizesafety and efficacy. Typically, dosage-effect relationships from invitro and/or in vivo tests initially provide useful guidance on theproper doses for subject administration. Studies in animal models areoften used for guidance regarding effective dosages for treatment of adisorder in accordance with a particular agent. In terms of treatmentprotocols, it should be appreciated that the dosage to be administeredwill depend on several factors, including the particular agent that isadministered, the route administered, the physical state of theparticular agent, the condition of the particular subject, etc.

EXAMPLE

By measuring the potency of the cannabis hash concentrate, it ispossible to consistently blend the capsules into specific strengths asmeasured by milligrams of THC in that capsule. For example, if thepotency of the cannabis component is 42% (wt), this means there are 420milligrams of THC per gram of the cannabis component. To produce acapsule containing 30 milligrams of THC, my composition must be blendedto contain 1/14^(th) of a gram of cannabis component (420/30=14). Thecomposition for a 60 milligram strength THC capsule is blended tocontain 117^(th) of a gram (420/60=7) of the cannabis component. Thecomposition for a 100 milligram strength THC capsule will contain1/4.2th of a gram (420/100=4.2) capsules per gram of the cannabiscomponent.

Batches of the composition may conveniently be blended in quantitiesadequate to produce 1,000 capsules. This batch size helps to ensureuniform homogeneity in the mixture and allows for accurate productiontracking. Production tracking notes the date of manufacture, thecannabis strain, and a code referring back to the laboratory testingreport for potency, absence of pesticides, and CFU count.

To produce 1,000 capsules containing 30 milligram strength THC, thecalculations are as follows: 30 mg. THC×1,000 capsules=30,000 mg. ofTHC. If the cannabis component in this example tested at 42% potency, itcontains 420 mg. of THC per gram of cannabis component, an amount(30,000/420) equaling 71.43 grams of cannabis component is required tomake 1,000 capsules. For 30 mg. and 60 mg. strengths I use eithergelatin or vegetarian size 0 (zero) capsules. For 100 mg. strength I usegelatin or vegetarian size 00 (zero zero) capsules. A size 0 capsule iscalculated to hold 0.44 grams of blended medicine. A size 00 capsule iscalculated to hold 0.62 grams of blended medicine.

My formulation typically uses 0.10 grams of soy lecithin in each capsulefor all three strengths −30, 60, and 100 mgs. Soy lecithin at 0.10 gramsper capsule is a constant in this example of the composition. The amountof cannabis component used depends on a combination of the potencymeasured in the laboratory (for example 42%) and the production strength−30, 60, or 100 mg. The third component (hemp seed powder) is added byweight so that the total blended formulation of each of the 30 and 60mg. strengths weighs exactly 440 grams for a production run of 1,000capsules. The total blended formulation for the 100 mg strength will beexactly 620 grams.

Therefore, for a cannabis component potency of 42% (wt) and a productionof 1,000 capsules at 60 mg strength, the weights of each component wouldbe as follows:

-   -   a.) 60 mg. of THC per capsule×1,000 capsules=60,000 mgs. of THC.    -   b.) 60,000/420 (42% potency)=143 grams of cannabis component    -   c.) plus 100 grams of soy lecithin=243 grams.    -   d.) the total weight needed to fill a size 0 capsule is 440        grams; the amount of hemp seed powder needed is calculated by:        440−143−100=197 grams of hemp seed powder.

Utilizing a higher potency cannabis component means that a smalleramount of cannabis component is needed in the formulation. For exampleusing a cannabis component of 60% (600 mg per gram of cannabiscomponent) only 100 grams of cannabis component is needed. The 1,000capsules will still contain 100 grams of soy lecithin. But the amount ofhemp seed powder needed to fill the 1,000 capsules is increased to 240grams.

I claim as my invention:
 1. A composition comprising: a.) powdered hempseed, b.) lecithin, and c.) cannabis.
 2. The composition of claim 1where the lecithin comprises soy lecithin.
 3. The composition of claim 1where the composition is in the form of a hard-shelled gelatin or plantvegetarian capsule or tablet.
 4. The composition of claim 1 furthercomprising one or more excipients.
 5. A kit comprising the compositionof claim 1 in multiple dosage forms, a package, and directions for use.6. A method for producing the composition of claim 1 comprising thesteps of: a.) mixing powdered hemp seed, lecithin, and cannabis to forma mixture, b.) grinding the mixture formed in step a.), and c.) heatingthe mixture to decarboxylate any THC-carboxy present in the cannabis. 7.A method for producing the composition of claim 3 comprising the stepsof: a.) mixing powdered hemp seed, lecithin, and cannabis to form amixture, b.) grinding the mixture formed in step a.), c.) heating themixture to decarboxylate any THC-carboxy present in the cannabis, d.)introducing the mixture containing the decarboxylated THC intohard-shelled gelatin or plant vegetarian capsules or forming tablets.